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Vitamin D + Omega-3 for Depression (VITAL-DEP Trial)

N/A
Waitlist Available
Led By Olivia I Okereke, MD, SM
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No history of major neurologic disorder or delirium episode in the past 12 months
No core major depressive disorder symptoms for a period of two or more weeks in the past two years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, follow-up year 1, follow-up year 2, follow-up year 3, follow-up year 4, and follow-up year 5
Awards & highlights

VITAL-DEP Trial Summary

This trial is studying whether taking vitamin D3 or omega-3 fatty acids supplements reduces the risk of developing cancer, heart disease, and stroke. This study will also examine whether either of these supplements reduces the risk of clinical depression or improves mood scores over time.

Who is the study for?
This trial is for adults in the VITAL study without a history of major neurological disorders, clinical hypothyroidism, significant depression, or recent substance abuse. They shouldn't be on psychotherapy or psychotropics (except mild sedatives) and must not have had core depressive symptoms for two weeks in the past two years.Check my eligibility
What is being tested?
The VITAL-DEP study tests if daily supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram fish oil) can prevent clinical depression and improve mood over time compared to placebos in individuals without prior cancer, heart disease, or stroke.See study design
What are the potential side effects?
Potential side effects from omega-3s may include a fishy aftertaste, upset stomach, and nausea. Vitamin D might cause fatigue, weakness, dry mouth or a metallic taste. Placebos typically have no active ingredients but can still result in side effects due to the placebo effect.

VITAL-DEP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't had a major neurological disorder or delirium in the last year.
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I haven't had major depression symptoms for 2+ weeks in the last 2 years.
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I have never been diagnosed with overt hypothyroidism.
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I am not currently experiencing significant depression.

VITAL-DEP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, follow-up year 1, follow-up year 2, follow-up year 3, follow-up year 4, and follow-up year 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, follow-up year 1, follow-up year 2, follow-up year 3, follow-up year 4, and follow-up year 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mood Scores
Number of Participants With a Depression Event
Other outcome measures
Number of Participants With a Recurrent Depression Event
Number of Participants With an Incident Depression Event

VITAL-DEP Trial Design

4Treatment groups
Active Control
Group I: Vitamin D + fish oil placeboActive Control2 Interventions
Vitamin D3 (cholecalciferol), 2000 IU per day Fish oil placebo
Group II: Vitamin D placebo + fish oil placeboActive Control2 Interventions
Vitamin D placebo Fish oil placebo
Group III: Vitamin D + fish oilActive Control2 Interventions
Vitamin D3 (cholecalciferol), 2000 IU per day Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA])
Group IV: Vitamin D placebo + fish oilActive Control2 Interventions
Vitamin D placebo Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA])

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,599 Previous Clinical Trials
11,444,161 Total Patients Enrolled
27 Trials studying Depression
97,404 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,774 Previous Clinical Trials
2,655,950 Total Patients Enrolled
664 Trials studying Depression
233,625 Patients Enrolled for Depression
Olivia I Okereke, MD, SMPrincipal InvestigatorBrigham and Women's Hospital

Media Library

Fish Oil Placebo Clinical Trial Eligibility Overview. Trial Name: NCT01696435 — N/A
Depression Research Study Groups: Vitamin D + fish oil placebo, Vitamin D placebo + fish oil placebo, Vitamin D + fish oil, Vitamin D placebo + fish oil
Depression Clinical Trial 2023: Fish Oil Placebo Highlights & Side Effects. Trial Name: NCT01696435 — N/A
Fish Oil Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT01696435 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other experiments that have looked into the effects of Vitamin D and fish oil together?

"Currently, 17 studies pertaining to the combination of Vitamin d and fish oil are in progress. 4 trials have already reached Phase 3 of development while 34 sites across Boston, Massachusetts are running various experiments."

Answered by AI

Is there an ongoing call for participants at this moment?

"The clinicaltrials.gov portal indicates that this medical study, which was originally posted on July 1st 2010 and last modified on February 28th 2022, is not currently recruiting patients. Despite this trial being inactive right now, there are 1320 other studies actively searching for participants."

Answered by AI

How many individuals are taking part in this clinical investigation?

"This medical research is no longer accepting enrollees. Initially posted on July 1st 2010, the last update occurred 28th of February 2022. If you're searching for other studies to join, there are 1303 current clinical trials seeking individuals with depression and 17 investigations recruiting participants for Vitamin d + fish oil therapy."

Answered by AI

Is this the inaugural venture of its type?

"Since 2005, Vitamin d + fish oil has been the focus of several clinical trials. The initial venture was established by Abbott in 2005 and involved 15480 participants. Afterward, this medication earned Phase 4 drug approval and is now being explored through 17 active studies located in 11 countries across 7 cities."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
What site did they apply to?
Brigham and Women's Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
~1251 spots leftby Mar 2025